Preliminary Evaluation of a Prehabilitation Program for Adults Awaiting Elective Heart Surgery and at Increased Risk of Postoperative Complications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Recruitment Rate (%)
研究概览
简要总结
The goal of this study is to learn if an exercise-based prehabilitation program can help people who are waiting for heart surgery and are at higher risk of complications recover better.
The main questions it aims to answer are:
Can a home-based prehabilitation program prescribed by a physiotherapist be done safely and realistically before heart surgery?
Participants will:
Take part in a personalized exercise program for a 8 to 16 weeks before surgery
Do breathing muscle training at home
Meet with a physiotherapist once a week, either in person or by video call
Be assessed before and after the program
Researchers will compare the postoperative results with those of patients who received usual care only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A high risk of perioperative and postoperative complications. This risk is determined based on the predictive thresholds for postoperative complications.
- •A waiting period of at least 8 weeks.
- •Access to a smartphone, tablet, or computer for videoconference visits.
排除标准
- •Unstable angina, malignant arrhythmias, active endocarditis/myocarditis, myocardial infarction within the last 2 weeks, left main coronary artery disease ≥ 50% on coronary angiography, severe aortic stenosis, severe mitral insufficiency, and decompensated heart failure.
- •Any other acute condition affecting vital signs or causing significant symptoms.
- •Physical or cognitive impairment limiting the ability to participate in the program.
研究组 & 干预措施
Prehab group
Supervised by a physiotherapist, the program includes an initial functional assessment, individualized training (breathing exercises, aerobic and strengthening exercises), and weekly follow-up via videoconference or phone.
干预措施: Exercise (Other)
结局指标
主要结局
Recruitment Rate (%)
时间窗: From enrollment to the end of treatment at maximum 16 weeks
Proportion of eligible candidates who enroll in the study. Recruitment rate will be calculated as the number of participants enrolled divided by the number of eligible candidates, multiplied by 100.
Adherence Rate (%)
时间窗: From enrollment to the end of treatment at maximum 16 weeks
Proportion of participants who complete at least 70% of prescribed exercise sessions. Calculated as the number of participants meeting this threshold divided by the total number enrolled, multiplied by 100.
Program Safety - number of participants experiencing exercise-related adverse events
时间窗: From enrollment to the end of treatment at maximum 16 weeks
Count of participants experiencing one or more adverse events during the program, including angina, arrhythmias, myocardial infarction, acute heart failure, or sudden cardiac death of cardiac origin.
Participant Satisfaction - likelihood to recommend
时间窗: From enrollment to the end of treatment at maximum 16 weeks
Among participants who complete the program, the self-reported likelihood of recommending the program to others, measured on a numeric rating scale from 0 ("not at all likely") to 10 ("extremely likely").
Participant Satisfaction - likelihood to repeat
时间窗: From enrollment to the end of treatment at maximum 16 weeks
Among participants who complete the program, the self-reported likelihood of participating in the program again, measured on a numeric rating scale from 0 ("not at all likely") to 10 ("extremely likely").
次要结局
- Maximal Inspiratory Pressure (cmH2O)(From enrollment to the end of treatment at maximum 16 weeks)
- Diaphragm Thickening Fraction (%)(From enrollment to the end of treatment at maximum 16 weeks)
- Grip Strength (kg)(From enrollment to the end of treatment at maximum 16 weeks)
- 5-repetition-sit-to-stand Test - Lower Limb Strength (seconds)(From enrollment to the end of treatment at maximum 16 weeks)
- 5-meter Gait Speed (seconds)(From enrollment to the end of treatment at maximum 16 weeks)
- Functional Capacity - six-minute walk distance (meters)(From enrollment to the end of treatment at maximum 16 weeks)
- Number of participants with postoperative pulmonary complications(From the day of surgery through hospital discharge (average of 10 days))
- Duration of postoperative mechanical ventilation (hours)(From ICU admission after surgery until extubation (within hospital stay, average 24-72 hours))
- Recovery of Mobility - Postoperative day of first mobilization (day out of bed)(Un average of 1 - 3 days)
- Recovery of Mobility - Postoperative day of first ambulation(An average of 3 - 6 days)
- Length of Postoperative Hospital Stay (days)(From the day of surgery through hospital discharge (average of 10 days))
研究者
Andre Denault
Anesthésiologiste
Montreal Heart Institute